The oncology specific domains TU, TR and RS: What to know as a statistical analyst

Size: px

Start display at page:

Download "The oncology specific domains TU, TR and RS: What to know as a statistical analyst"

Donna Melton
5 years ago
Views:

specific domains TU, TR and RS: What to know as a

1 Your statistical health consultancy CHM staying healthy CRO getting healthy TEMP WORK team health The oncology specific domains TU, TR and RS: What to know as a statistical analyst PhUSE EU Connect 2018, Frankfurt, 5 th Oct 2018

2 Agenda 1. Motivation 2. Exemplary study Oncology specific domains RECIST 3. Summary 1

3 Motivation Typical oncological endpoints hard to assess Standardized criteria essential: RECIST Standardized Data Structure (CDISC) Tumor package in SDTM: 3 domains Goal: Data Model Medical Background Improved Programming 2

4 Study setting Accompany Steve on his way 67 years old / diagnosed with lung cancer Participation in phase I study Baseline tumor assessment at screening visit Additional assessments every 6 weeks 3

5 Screening visit CT scan of lung: 3 Lesions Categorization according to RECIST: 1. Measurable/non-measurable Longest diameter 10 mm à measurable 2. Target/non-target Max. of 5 target lesions in total Max. of 2 per organ 4

6 Screening visit TULINKID TUTEST TUORRES TULOC TUMETHOD VISIT T01 Tumor Identification TARGET LUNG CT SCAN Screening T02 Tumor Identification TARGET LUNG CT SCAN Screening NT01 Tumor Identification NON-TARGET LUNG CT SCAN Screening 5

7 Screening visit TRLNKID T01 T02 NT01 TRLNKGRP A1 A1 A1 A1 TRTEST TRORRES TRORRESU VISIT Diameter 20 mm Screening Diameter 15 mm Screening Sum of Diameter 35 mm Screening Tumor State PRESENT Screening 6

8 TR Week 6 TRLNKID TRLNKGRP TRTEST TRORRES TRORRESU VISIT A1 Sum of Diameter 35 mm Screening T01 A2 Diameter 13 mm Week 6 T02 A2 Diameter 17 mm Week 6 A2 Sum of Diameter 30 mm Week 6 A2 A2 Percent Change from Baseline in Sum of Diameter Percent Change from Nadir in Sum of Diameter -14 % Week 6-14 % Week 6 NT01 A2 Tumor State PRESENT Week 6 7

9 Response evaluation in target lesions CR: Disappearance of all target lesions PR: 30% decrease in sum of diameter SD: no PR, neither PD PD: 20% increase in sum of diameter Absolute increase of 5 mm 8

10 Response evaluation in non-target lesions CR: Disappearance of all non-target lesions Non-CR/Non-PD: Persistence of non-target lesions PD: Unequivocal progression 9

11 RS Week 6 Target Lesions: Change from BL / Nadir = -14% Non Target Lesions: Present RSLNKGRP RSTEST RSCAT RSORRES VISIT Target Response Recist 1.1 SD Week 6 Non-Target Response Recist 1.1 Non-CR/Non-PD Week 6 A2 Overall Response Recist 1.1 SD Week 6 10

12 TRLNKID TRLNKGRP TRTEST TRORRES TRORRESU VISIT A1 Sum of Diameter 35 mm Screening A2 Sum of Diameter 30 mm Week 6 T01 A3 Diameter 18 mm Week 12 T02 A3 Diameter 22 mm Week 12 A3 Sum of Diameter 40 mm Week 12 A3 A3 TR Week 12 Percent Change from Baseline in Sum of Diameter Percent Change from Nadir in Sum of Diameter 14 % Week % Week 12 NT01 A3 Tumor State PRESENT Week 12 11

13 RS Week 12 Target Lesions: Change from BL / Nadir = 14% / 33% Non Target Lesions: Present RSLNKGRP RSTEST RSCAT RSORRES VISIT A2 Overall Response Recist 1.1 SD Week 6 Target Response Recist 1.1 PD Week 12 Non-Target Response Recist 1.1 Non-CR/Non-PD Week 12 A3 Overall Response Recist 1.1 PD Week 12 12

14 Summary TU TR RS Ø Initial identification of tumor lesions Ø One record per tumor Ø Quantitative/qualitative measurements Ø Support of response evaluation Ø Response evaluation based on TR 13

15 Summary Good programming is essential... knowing the medical context is even better 14

16 Thank you! Any questions? 15

17 References Clinical Data Interchange Consortium (CDISC) Submission Data Standards Team. Study Data Tabulation Model Implementation Guide: Human Clinical Trials. Version Eben J. Implementation of oncology specific SDTM domains. Paper PP06. Phuse Eisenhauer E.A., Therasse, P., Bogaerts, J., Schwartz, L.H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., Rubinstein, L., Shankar, L., Dodd, L., Kaplan, R., Lacombe, D., Verwij, J. New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1). European Journal of Cancer. Vol ; ( 16

CDISC Journey in Solid Tumor using RECIST 1.1 Kevin Lee PhUSE conference Oct 14th, 2013

CDISC Journey in Solid Tumor using RECIST 1.1 Kevin Lee PhUSE conference Oct 14th, 2013 Disclaimer Any views or opinions presented in this presentation are solely those of the author and do not necessarily